Cognitive-behavioral Therapy vs. Light Therapy for Preventing SAD Recurrence

NCT01714050 | Completed

• 1 other identifier: R01MH078982
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

Major depression is a highly prevalent, chronic, and debilitating mental health problem with significant social cost that poses a tremendous economic burden. Winter seasonal affective disorder (SAD) is a subtype of recurrent major depression involving substantial depressive symptoms that adversely affect the family and workplace for about 5 months of each year during most years, beginning in young adulthood. This clinical trial is relevant to this public health challenge in seeking to develop and test a time-limited (i.e., acute treatment completed in a discrete period vs. daily treatment every fall/winter indefinitely), palatable cognitive-behavioral treatment with effects that endure beyond the cessation of acute treatment to prevent the annual recurrence of depression in SAD. Aim (1) To compare the long-term efficacy of cognitive-behavioral therapy (CBT) and light therapy on depression recurrence status, symptom severity, and remission status during the next winter season (i.e., the next wholly new winter season after the initial winter of treatment completion), which we argue to be the most important time point for evaluating clinical outcomes following SAD intervention. Hypothesis: CBT will be associated with a smaller proportion of depression recurrences, less severe symptoms, and a higher proportion of remissions than light therapy in the next winter. The study is designed to detect a clinically important difference between CBT and light therapy in depressive episode recurrences during the next winter, the primary endpoint, in an intent-to-treat analysis. Aim (2) To compare the efficacy of CBT and light therapy on symptom severity and remission status at post-treatment (treatment endpoint). Hypothesis: CBT and light therapy will not differ significantly on post-treatment outcomes.

Conditions

Seasonal Affective Disorder (SAD); Winter Depression; Major Depressive Disorder, Recurrent, With Seasonal Pattern

Keywords

seasonal affective disorder; winter depression; cognitive-behavioral therapy; light therapy

Outcome Measures

Primary Outcomes (1)

• Depression recurrence status on the Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD; Williams et al., 1992)

  The SIGH-SAD (Williams et al., 1992), the most commonly used clinical assessment device for detecting changes in SAD symptoms in light therapy research, includes the 21-item Structured Interview Guide for the Hamilton Rating Scale for Depression (HAM-D) and a supplementary 8-item subscale to assess atypical depressive symptoms associated with SAD. The primary outcome measure is SIGH-SAD recurrence status at the next winter followup. A trained rater, blind to the treatment condition, will administer the SIGH-SAD at pre-treatment, treatment weeks 1-5, post-treatment, summer followup, next winter followup, and second winter followup. A second blinded rater will rate audiotapes of the SIGH-SADs to assess inter-rater reliability.

  next winter followup (January or February of the next winter, approximately a year after study treatment)

Secondary Outcomes (2)

• Beck Depression Inventory-Second Edition (BDI-II; Beck et al., 1996)

  baseline, mid-treatment (week 3), post-treatment (week 6), summer followup (August), next winter followup (January or February or the next winter), and the second winter followup (January or February two winters later)

• Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD)

  baseline, weekly during treatment (weeks 1-5), post-treatment (week 6), summer followup (August), next winter followup (January or February of the next winter), second winter followup (January or February two winters later)

Study Arms (2)

Cognitive-Behavioral Therapy (CBT)

EXPERIMENTAL

The CBT is a SAD-tailored version of Beck et al.'s (1979) cognitive therapy for depression called "Coping with the Seasons" (Rohan, 2008). The rationale addresses environmental changes, thoughts, and behaviors in SAD onset and maintenance. It seeks to change behaviors and thoughts to improve coping with winter. Behaviors that promote enjoyment in the winter are increased. Negative thoughts that interfere with self-esteem and negative thoughts about winter are identified and addressed. A relapse-prevention component addresses early identification of negative anticipatory thoughts about winter and SAD-related behavior changes, using the CBT skills learned to cope with subsequent winter seasons, and development of a personalized relapse-prevention plan. The CBT sessions are administered twice a week over 6 weeks (total of 12 sessions) with 4-8 participants per group. The CBT is led by one of three licensed Ph.D.-level psychologists working on the project.

Behavioral: Cognitive-Behavioral Therapy (CBT)

Light Therapy (LT)

EXPERIMENTAL

LT will be initiated at 30-minutes in the morning at home, first thing upon awakening, using a light box with an ultraviolet shield that emits 10,000-lux of white fluorescent light. After the first week, an M.D. light therapy consultant will recommend individually-tailored, clinical adjustments to the duration and timing of light use to maximize response and reduce any reported side effects. For each of the 6-weeks of LT, LT participants will complete a Light Therapy Side Effects Questionnaire to assess side effects attributed to LT. Participants will keep daily LT compliance diaries to record the timing and duration of LT. After the 6-weeks of monitoring, participants may choose to continue using the light box through April. We will offer LT participants who wish to use light therapy in the next fall/winter season access to our light boxes if they agree to followup with a physician or other qualified professional for monitoring and side effects management.

Device: Light Therapy (LT)

Interventions

Cognitive-Behavioral Therapy (CBT) BEHAVIORAL

Cognitive-Behavioral Therapy (CBT)

Light Therapy (LT) DEVICE

SunRay (SunBox Company, Gaithersburg, MD)

Light Therapy (LT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 or older
• meet DSM-IV criteria for Major Depression, Recurrent, with Seasonal Pattern
• meet Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder Version (SIGH-SAD) criteria for a current SAD episode

You may not qualify if:

• past light therapy or cognitive-behavioral therapy for SAD
• presence of a comorbid Axis I disorder that requires immediate treatment
• acute and serious suicidal intent
• positive laboratory findings for hypothyroidism
• plans for major vacations or absences from the study area through March

Sponsors & Collaborators

• University of Vermont: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Vermont, Psychology Department

Burlington, Vermont, 05405-0134, United States

Location

Related Publications (7)

• Rohan KJ, Terman JM, Iyiewuare P, Perez J, Camuso JA, Postolache TT, DeSarno MJ, Vacek PM. Prospectively assessed summer mood status in major depression, recurrent with seasonal pattern: Evidence for SAD's construct validity. J Affect Disord. 2024 Mar 15;349:32-38. doi: 10.1016/j.jad.2023.12.070. Epub 2023 Dec 30.

  PMID: 38160889 DERIVED

• Rohan KJ, Burt KB, Norton RJ, Perez J, Iyiewuare P, Terman JM. Change in Seasonal Beliefs Mediates the Durability Advantage of Cognitive-Behavioral Therapy Over Light Therapy for Winter Depression. Behav Ther. 2023 Jul;54(4):682-695. doi: 10.1016/j.beth.2022.11.002. Epub 2022 Dec 7.

  PMID: 37330257 DERIVED

• Terman JM, Rohan KJ, Stickle TR, Wernhoff A. Personality Pathology in Winter Depression: Prevalence and Treatment Trajectories in Cognitive-Behavioral Therapy and Light Therapy. Behav Ther. 2023 Mar;54(2):361-374. doi: 10.1016/j.beth.2022.10.002. Epub 2022 Nov 2.

  PMID: 36858765 DERIVED

• Rohan KJ, Burt KB, Camuso J, Perez J, Meyerhoff J. Applying experimental therapeutics to examine cognitive and chronological vulnerabilities as mediators of acute outcomes in cognitive-behavioral therapy and light therapy for winter depression. J Consult Clin Psychol. 2020 Aug;88(8):786-797. doi: 10.1037/ccp0000499.

  PMID: 32700956 DERIVED

• Rohan KJ, Meyerhoff J, Ho SY, Evans M, Postolache TT, Vacek PM. Outcomes One and Two Winters Following Cognitive-Behavioral Therapy or Light Therapy for Seasonal Affective Disorder. Am J Psychiatry. 2016 Mar 1;173(3):244-51. doi: 10.1176/appi.ajp.2015.15060773. Epub 2015 Nov 5.

  PMID: 26539881 DERIVED

• Rohan KJ, Mahon JN, Evans M, Ho SY, Meyerhoff J, Postolache TT, Vacek PM. Randomized Trial of Cognitive-Behavioral Therapy Versus Light Therapy for Seasonal Affective Disorder: Acute Outcomes. Am J Psychiatry. 2015 Sep 1;172(9):862-9. doi: 10.1176/appi.ajp.2015.14101293. Epub 2015 Apr 10.

  PMID: 25859764 DERIVED

• Rohan KJ, Evans M, Mahon JN, Sitnikov L, Ho SY, Nillni YI, Postolache TT, Vacek PM. Cognitive-behavioral therapy vs. light therapy for preventing winter depression recurrence: study protocol for a randomized controlled trial. Trials. 2013 Mar 21;14:82. doi: 10.1186/1745-6215-14-82.

  PMID: 23514124 DERIVED

MeSH Terms

Conditions

Seasonal Affective Disorder; Depressive Disorder, Major; Recurrence

Interventions

Cognitive Behavioral Therapy; Phototherapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Therapeutics

Study Officials

• Kelly J Rohan, Ph.D.

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 25, 2012
• Study Start: July 1, 2008
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

US (1)